Impact of Clinical Pharmacist-Led Intervention on Management of Diabetic Hypertensive Patients in Eastern Nepal

NCT05707481 | Completed DMC

• 1 other identifier: 382/2022 PhD
• Study Type: interventional
• Target: 92
• Locations: 1 country
• Sites: 1

Brief Summary

Diabetic-Hypertensives are at a higher risk of premature microvascular and macrovascular complications than diabetes alone. Proper lifestyle management, diet, disease monitoring, and medication adherence is essential in achieving desired therapeutic outcomes, preventing complications and improving those patients' Health-Related Quality of Life (HRQoL). Pharmacists are the most accessible healthcare professionals to the public and have a crucial role in optimizing treatment outcomes in patients with chronic diseases such as diabetes and hypertension. Experimental trials' demonstrating the potential roles of pharmaceutical services is scarce in the literature, particularly in developing countries of south Asia. Therefore, the investigators plan to conduct a prospective-interventional trial to determine the potential impacts of pharmacist-supervised educational intervention on the management of "Type II diabetic with comorbid hypertension" patients. Patient data will be collected using patient's clinical profile forms, General Medication adherence Scale (GMAS), Patients Satisfaction towards pharmaceutical services (PSPSQ), Health Related-KAP questionnaires. Data will be verified, stored, entered into databases, and analyzed according to the data management plan. The findings will be compared in terms of clinical and nonclinical outcome measures between the control and test groups to ascertain the conclusion.

Conditions

Type 2 Diabetes; Hypertension

Outcome Measures

Primary Outcomes (6)

• Change in blood pressure

  Assessed with measurement of Systolic and diastolic blood pressure in mmHg using sphygmomanometer

  baseline, follow up at 3 months and 6 months respectively

• Change in blood glycemic profile

  Assessed with measurement of Fasting Blood Sugar (FBS) and Post Prandial Blood Sugar (PPBS) in mg/dl.

  baseline, follow up at 3 months and 6 months respectively

• change in glycosylated hemoglobin (HbA1C) level

  assessed from patients glycosylated hemoglobin (HbA1C) level test, measured in percent (%)

  baseline, follow up at 3 months and 6 months respectively

• Impact of Intervention in Patients Medication Adherence

  It will be measured using translated and validated Nepalese version of the 11-item Novel general medication adherence Scale (GMAS) questionnaire divided into three categories based on a four-level Likert scale. GMAS tools provide a wide range of components, including disease and medication burden, patient behavior both intentional and unintentional, and cost-related burden associated with non-adherence. Higher Scores better the outcomes, measured within categories and overall adherence level.

  baseline, follow up at 3 months and 6 months respectively

• Compare patients perceived Satisfaction of pharmaceutical care services

  This will be assessed by using Nepali version of Patients Perceived satisfaction of Pharmacist care (PSPSQ. 2 ) questionnaire. This tool comprises 20 items questionnaire divided into three dimensions based on a four-point Likert scale. Dimensions include quality of care, pharmacist-patient relationships, and overall satisfaction. Higher scores represent better outcomes, measured within domains and overall satisfaction levels.

  baseline, follow up at 3 months and 6 months respectively

• Change in Health related Quality of Life

  Translated Nepali version of Euro 5 D 5 L questionnaire measures will be used to measure patients' health-related quality of life (HRQoL). This questionnaire created by the European Quality of Life Group (EuroQol Group) measure HRQoL in five dimension Mobility, Self-Care, Usual Activities, Pain/Discomfort, and Anxiety/Depression. Each dimension has five levels to describe the severity: no problem, slight problem, moderate problem, severe problem, and unable (very severe). The outcomes will be measured in the overall health utility index value. The index value ranges from -1 to 1 (0 indicates death, \<0 indicates worse than death, and 1 indicates full health)

  baseline, follow up at 3 months and 6 months respectively

Secondary Outcomes (2)

• Change in routine clinical laboratory parameters of patients Lipid Profile test.

  baseline, follow up at 3 months and 6 months respectively

• Change in Patients health related Knowledge, Attitude and Practice

  baseline, follow up at 3 months and 6 months respectively

Study Arms (2)

Control group (Usual Standard Care)

NO INTERVENTION

Control group patient will undergo routine care by their physician and nurses. However, the investigator will only provide basic counseling regarding drug prescribed during discharge to the patients. In another term "Usual care" will be provided to the patients

Intervention Group (Clinical Pharmacist-led educational Intervention)

OTHER

In addition to routine care by physician and nurses, Patients in interventional group will receive two consecutive face to face interview and counseling of 20-40 minutes during the baseline period and the first follow-up period at 3-month by clinical pharmacist. Teaching and counseling session involves information on various non-pharmacological and pharmacological disease management strategies.

Other: Clinical Pharmacist-Led Educational Intervention

Interventions

Clinical Pharmacist-Led Educational Intervention OTHER

Non Pharmacological management strategies include information related to life style modification, healthy dietary habits, physical activity and stress management techniques. In contrast, pharmacological educational intervention involves disease -related information ( diabetes/hypertension sign and symptoms, risk factor, complications, self-monitoring of blood pressure/glucose, symptoms and management of hypoglycemia/hypotension etc. ) and drug related information ( prescribed drug name, indication, contraindication, adverse effects etc.) as well as importance of adherence to prescribed medication and strategies to minimize DRPs issues. These teaching sessions will be carried out with the help of verbal communication, audio visual demonstration (including charts,pictorial etc) and information leaflets. Furthermore, a copy of educational package would be given to each participant for reference and guidance.

Intervention Group (Clinical Pharmacist-led educational Intervention)

Eligibility Criteria

• Age: 40 Years - 68 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male and female patients aged 40 to 68 years.
• Clinically diagnosed with type II diabetes mellitus with hypertension as co-morbidity.
• Minimum one year of the medical history of diabetic and hypertension.
• Minimum 6 months on antidiabetic as well as antihypertensive medication therapy.
• Patients willing to participate in the study and those providing written informed consent for participation.

You may not qualify if:

• Patients with Type I diabetes mellitus, Diabetic insipidus, Gestational diabetes or other forms of diabetes.
• Presence of other chronic disease co-morbidity other than hypertension and diabetes complications.
• Mentally incompetent patients, Pregnant, critically ill patients (requiring hospital admission).
• Patients have tuberculosis, Corona virus, and other highly communicable diseases.
• Those patients not willing to performing routine follow-up visit.

Sponsors & Collaborators

• Chettinad Academy of Research and Education (Deemed to be University): lead
• Purbanchal University: collaborator

Study Sites (1)

Purbanchal University Hospital

Gothgaun,Sundar Haraicha Municipality, Morang, Koshi, 56600, Nepal

Location

Related Publications (4)

• Naqvi AA, Hassali MA, Jahangir A, Nadir MN, Kachela B. Translation and validation of the English version of the general medication adherence scale (GMAS) in patients with chronic illnesses. J Drug Assess. 2019 Feb 6;8(1):36-42. doi: 10.1080/21556660.2019.1579729. eCollection 2019.

  PMID: 30863660 BACKGROUND

• Shrestha R, Sapkota B, Khatiwada AP, Shrestha S, Khanal S, Kc B, Paudyal V. Translation, Cultural Adaptation and Validation of General Medication Adherence Scale (GMAS) into the Nepalese Language. Patient Prefer Adherence. 2021 Aug 27;15:1873-1885. doi: 10.2147/PPA.S320866. eCollection 2021.

  PMID: 34475753 BACKGROUND

• Sakharkar P, Bounthavong M, Hirsch JD, Morello CM, Chen TC, Law AV. Development and validation of PSPSQ 2.0 measuring patient satisfaction with pharmacist services. Res Social Adm Pharm. 2015 Jul-Aug;11(4):487-98. doi: 10.1016/j.sapharm.2014.10.006. Epub 2014 Oct 22.

  PMID: 25481330 BACKGROUND

• Shrestha S, Sapkota B, Thapa S, K C B, Khanal S. Translation, cross-cultural adaptation and validation of Patient Satisfaction with Pharmacist Services Questionnaire (PSPSQ 2.0) into the Nepalese version in a community settings. PLoS One. 2020 Oct 9;15(10):e0240488. doi: 10.1371/journal.pone.0240488. eCollection 2020.

  PMID: 33035243 BACKGROUND

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Hypertension

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Prasanna Dahal, PharmD

  Chettinad Academy of Research and Education (Deemed to be University)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD Research Scholar

Study Record Dates

• First Submitted: January 6, 2023
• First Posted: February 1, 2023
• Study Start: August 22, 2023
• Primary Completion: July 2, 2024
• Study Completion: July 4, 2024
• Last Updated: February 12, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

NE (1)